Rx Product News

JUNE 01, 2009

HOT R x Apidra SoloSTAR

Marketed by: Sanofi-aventis (Bridgewater, NJ) Indication: Sanofi-aventis announced FDA approval of the Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled, disposable pen containing the fast-acting insulin analog Apidra, which is indicated to improve glycemic control in adults and children 4 years of age and older with type 1 diabetes, or adults with type 2 diabetes. With Apidra SoloSTAR, patients do not have to change cartridges. The pen operates with low-injection force. Apidra SoloSTAR is expected to become available in pharmacies sometime this year. Dosage Form: 3-mL prefilled pen For More Information: www.apidra.com

Lexapro

Marketed by: Forest Laboratories (New York, NY) Indication: The FDA approved a supplemental new drug application for Lexapro (escitalo- pram oxalate) for the acute and main- tenance treatment of major depressive disorder (MDD) in adolescents 12 to 17 years of age. The approval makes Lexapro the second antidepressant to be approved for the treatment of MDD in adolescents. Believed to increase the availability of serotonin in the brain, Lexapro also is used for the acute treatment of generalized anxiety disorder in adults. Lexapro is contraindicated in patients taking monoamine oxidase inhibitors, pimozide, or in patients with hypersensitivity to escitalopram or citalopram. Dosage Form: Tablets: 5 mg, 10 mg (scored), and 20 mg (scored) Oral solution: 1 mg/mL For More Information: www.lexapro.com

Afinitor

Marketed by: Novartis (East Hanover, NJ) Indication: Afinitor oral tablets (everolimus) have received FDA approval for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. A kinase inhibitor, Afinitor is intended for advanced renal cell cancer patients for whom other kinase inhibitors, such as sunitinib or sorafenib, have failed. Afinitor is different from sunitinib and sorafenib in that they are multiple kinase inhibitors, and Afinitor blocks a specific protein known as the mammalian target of rapamycin or mTOR. The protein-blocking action disrupts the growth, division, and metabolism of cancer cells. Dosage Form: 5- and 10-mg tablets with no score For More Information: www.afinitor.com

Marketed by: Arcutis Pharmaceuticals (Redwood City, CA) Indication: The FDA has approved Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) for the once-daily treatment of acne vulgaris in patients 12 years of age and older. The gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide medication for once-daily treatment of both noninflammatory and inflammatory lesions of acne. Acanya is formulated in an aqueous-based, alcohol-free gel to provide enhanced bioavailability of benzoyl peroxide. In clinical trials, Acanya showed synergistic efficacy beyond that of the vehicle gel and either clindamycin or benzoyl peroxide alone. Dosage Form: Clindamycin phosphate 1.2% and benzoyl peroxide 2.5% in a topical gel in a 50-g jar For More Information: www.arcutis.com

Marketed by: Solvay Pharmaceuticals Inc (Marietta, GA) Indication: Solvay Pharmaceuticals Inc has announced FDA approval of Creon (pancrelipase) Delayed- Release Capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Creon is the first and only pancreatic enzyme product to receive FDA approval under new guidelines for the class. Slated for commercial availability in the third quarter of this year, the product is a new formulation of Creon. The currently marketed formulation of the drug will continue to be commercially available until the new product launches. Dosage Form: Capsules (dose by USP units of lipase): 6000, 12,000, and 24,000 For More Information: www.creon-us.com PrandiMet

Marketed by: Novo Nordisk (Princeton, NJ) and Sciele Pharmaceuticals (Atlanta, GA) Indication: Novo Nordisk and Sciele Pharmaceuticals announced the availability of PrandiMet (repaglinide and metformin HCl) tablets. PrandiMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are already treated with a meglitinide and metformin HCl or who have insufficient glycemic control on a meglitinide alone or metformin HCl alone. It is the first and only fixed-dose combination of Prandin and insulin sensitizer metformin HCl for the treatment of type 2 diabetes in the United States. Dosage Form: Tablets: 1 mg repaglinide/500 mg metformin HCl and 2 mg repaglinide/500 mg metformin HCl For More Information: http://prandimet.com